Know Cancer

or
forgot password

Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Squamous Cell Carcinoma

Thank you

Trial Information

Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer


Inclusion Criteria:



- Previously untreated squamous cell carcinoma of the oral cavity, oropharynx,
hypopharynx, or larynx.

- Stage III or IV disease (excluding T1N1, and T2N1 and metastatic disease).

- ECOG performance status less than or equal to 2.

- Absolute neutrophil count at least 1.5 X 10^9/L, platelet count at least 100 X
10^9/L, and hemoglobin > 9g/dL.

- Serum bilirubin < 1.25 times ULN and AST/ALT < 2.5 times ULN.

- Calculated creatinine clearance (Cockcroft-Gault) > 55 mL/min.

Exclusion Criteria:

- Metastatic Disease

- Primary cancers of the nasal and paranasal cavities and of the nasopharynx

- Significant intercurrent illness that will interfere with the Chemotherapy or
Radiation Therapy during the trial

- Symptomatic peripheral neuropathy > grade 2

- Clinically significant hearing impairment

- Significant cardiac disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Study period

Safety Issue:

No

Principal Investigator

ICD CSD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC5512

NCT ID:

NCT00174837

Start Date:

April 2005

Completion Date:

January 2008

Related Keywords:

  • Head and Neck Squamous Cell Carcinoma
  • Tirapazamine
  • Head and Neck Cancer
  • Cisplatin
  • Radiation
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Sanofi-Aventis Administrative Office Bridgewater, New Jersey  08807